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The Effects of Testosterone on Prostate Tissue (ACYP-1)

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University of Washington

Status and phase

Completed
Phase 1

Conditions

Contraception
Hypogonadism

Treatments

Drug: Placebo Testosterone gel
Drug: Placebo acyline
Drug: Testosterone gel
Drug: Acyline

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00161486
U 54 HD42454
03-9401-B

Details and patient eligibility

About

The purpose of this research study is to understand the effects of testosterone on the prostate. This knowledge will be used to help in the development of a safe male hormonal contraceptive and may impact the development of androgen replacement therapy in older men.

Full description

We will be administering two drugs: Testim (testosterone gel) and Acyline. Acyline is an experimental drug. We want to see their effects on levels of hormones in the blood and prostate. In addition, we will be examining the effects of these drugs on the expression of genes within the prostate.

Acyline suppresses LH and FSH, which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore, Acyline blocks testosterone production. In preliminary studies, a single injection of Acyline reversibly lowered the FSH, LH and testosterone levels in the blood for approximately 15 days. Prolonged low levels of LH and FSH cause suppression of sperm production in normal men. However, men may experience some side effects from the low levels of testosterone caused by acyline, thus exogenous testosterone is required to sustain normal male androgen and organ effects without suppressing spermatogenesis. This combination of drugs is a promising male contraceptive regimen. In addition, millions of older men are using testosterone replacement to treat male "andropause"; low level testosterone associated with aging. However, the effect of testosterone on the prostate is unknown. Studies examining the effect of testosterone on the prostate are needed.

Enrollment

13 patients

Sex

Male

Ages

35 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Males between 35 and 55, normal serum testosterone levels, normal gonadal function

Exclusion criteria

  • History of prostate cancer, PSA>2.0, AUA BPH symptom score >10, History of testosterone or anabolic steroid use, chronic medical illness or prostate disease, active serious infection or immunosuppression, history of a bleeding disorder or need for anticoagulation, abnormal digital rectal exam, abnormal prostate ultrasound, first degree relative with history of prostate cancer

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

13 participants in 3 patient groups, including a placebo group

1
Placebo Comparator group
Description:
Placebo acyline injections every two weeks (2 doses) + placebo testosterone gel daily for 4 weeks
Treatment:
Drug: Placebo acyline
Drug: Placebo Testosterone gel
2
Active Comparator group
Description:
Acyline 300 μg/kg every two weeks (2 doses) + placebo Testosterone gel daily for 4 weeks
Treatment:
Drug: Placebo Testosterone gel
Drug: Acyline
3
Active Comparator group
Description:
Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks + Testosterone gel 100 mg daily for 4 weeks
Treatment:
Drug: Testosterone gel
Drug: Acyline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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